P50 Series Dental Operative Unit and Accessories— 510(k) K171872

Name: FDA 510(k) clearance K171872
Creator: U.S. Food and Drug Administration
Published: 2018-04-26

Substantially Equivalent

Pelton & Crane

FDA 510(k) clearance K171872 for P50 Series Dental Operative Unit and Accessories, Substantially Equivalent on 2018-04-26. Applicant: Pelton & Crane. Device class: 1.

Clearance details

Applicant: Pelton & Crane
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2017-06-23
Decision date: 2018-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlotte, NC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.